Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: VELVERT (New antimicrobial wound dressing): Velvert is a soft, non-adherent herbal topical wound dressing patch that can suppress colonization and proliferation of bacteria within the d
Sponsors
Datt Mediproduct Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Male and female of age group between 18 to 70 years (Adult, Older Adult). 2. Subjects must be able to read and understand informed consent, and sign the informed consent to provide data for the study. 3. Subjects who allow their data to be collected for the study at predefined follow-up periods. 4. Female subject that is willing to take contraceptive pills for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. 5. Subjects suffering from infected wound with size less than 25/30 square centimeter. 6. Subjects having a traumatic infected wound with duration less than 1 month.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Subject unwilling or unable to comply with the follow up visits necessary for data collection. 2. Subject found positive for HIV, HBsAg and HCV. 3. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study. 4. Pregnant females. 5. Subject with Immunosuppression, corticosteroids or chemotherapy. 6. Subject with decision making impairment. 7. Subject with a severe comorbid disorder, not expected to survive more than 12 months. 8. Active foot infections. 9. Allergies to any material contained investigational devices. 10. Subjects with burn wounds, DFU, malignant ulcers, tubercular ulcers, leprotic ulcers, gangrenous ulcers, ischemic ulcers, bed sores. 11. Any other condition which, according to the judgment of the investigator, could interfere in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An FHO is considered to have occurred in a given patient if all the following composite endpoints are met: I. Total wound area (sum of areas of all present wounds on both limbs) has decreased, compared to baseline (Screening), by 100% at or before the scheduled last visit. II. Comparative evaluation of wounds through Bates-Jensen Wound Assessment Tool and assessment of wound photographs at each visit. III. Evaluate bacterial load before (Day 0), Day 8, Day 16 and on the last day (Day 24).Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| o Assessment of safety based on adverse events and incidences of wound complications like infection associated with a new antimicrobial wound dressing (VELVERT) compared to Sofra-tulle dressing, in infected wound. o Assessment of a new antimicrobial wound dressing (VELVERT) compared to Sofra-tulle dressing in infected wound by Investigators based on surgeonâ??s questionnaire. o Assessment of VELVERT efficacy based on reduction in subjectâ??s pain levelsTimepoint: 24 days | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi U.P.
Outcome results
None listed